U.S. Pat. No. 5,515,844 entitled “Method and Apparatus for Weaning Ventilator-Dependent Patients,” incorporated herein by reference in its entirety, discloses several adapter devices used in connection with methods for weaning ventilator-dependent patients who access oxygen from the ventilator through a tracheostomy tube. The methods include deflating the cuff on the patient's tracheostomy tube and supplying a continuous flow of oxygen or an air mixture through a transtracheal catheter fitted into the patient's tracheostomy tube and into the patient's lungs. In addition to weaning a ventilator-dependent patient from a ventilator, it has also been found that tracheotomized patients may benefit from receiving heated and/or humidified gas, such as oxygen, air, air/oxygen blend, etc., from a transtracheal catheter.
The adapter devices of the '844 patent include a tapered plug or cap to block the opening of the tracheostomy tube. However, the adapter devices of the '844 patent are generally not configured to directly attach to the security flange of the transtracheal catheter. More particularly, the adapter devices of the '844 patent are not configured to directly interconnect with the security flange of the transtracheal catheter sold under the trademark SCOOP® and manufactured by Transtracheal Systems, Inc. of Englewood, Colo., and described in U.S. Pat. Nos. 5,090,408 and 5,181,509, incorporated herein by reference in their entirety. As shown in FIG. 1, the transtracheal catheter 10 sold under the trademark SCOOP® includes a tube 14 having a connector 18 at is proximal end for attachment to an oxygen/air supply. In addition, the transtracheal catheter 10 has a distal end having a beveled end 22. The transtracheal catheter 10 is made of a bio-polymer of 70–90 Shore A durometer hardness that resists kinking and crushing. The transtracheal catheter 10 further includes a security flange 26 having two holes 30 for accepting a small chain (not shown) for maintaining the position of the transtracheal catheter 10 around the patient's neck.
Referring now to FIG. 2, a tracheostomy tube assembly 34 of the prior art is shown. The assembly 34 includes an outer cannula 38 and a sealing balloon 42 located adjacent the distal end 46 of the outer cannula 38. Positioned adjacent the proximal end 50 of the outer cannula 38 is a swivel neck flange 54 that is used to secure the assembly 34 to the neck of the patient. A flexible inflation tube 58 extends from the proximal end 50 of the outer cannula 38 to receive air to inflate the balloon 42 for sealing the outer cannula 38 within the trachea of the patient.
Referring now to FIG. 3, the outer cannula 38 includes a coupling mechanism or connector 62 for removably attaching an inner cannula 66 to the outer cannula 38. Comparing FIG. 3 to FIG. 2, the inner cannula 66 is partially removed from within the outer cannula 38. The inner cannula 66 includes a tube fitting 70 at its proximate end. The inner cannula 66 is designed to be completely removed from within the outer cannula 38 in order to allow the inner cannula 66 to periodically be cleaned and thereby provide a clean and clear passage for the flow of air to the patient.
While the adapter devices of the '844 patent may be utilized along a position of the tube 14 of the transtracheal catheter 10, the adapter devices of the '844 patent do not secure the transtracheal catheter in place. Rather, the transtracheal catheter is typically independently secured by a chain around the patient's neck. More specifically, the adapter devices of the '844 patent do not engage the security flange 26 of a transtracheal catheter 10. Therefore, it would be advantageous to provide a tracheostomy tube adapter for direct use with the security flange 26 of the transtracheal catheter 10 sold under the trademark SCOOP®. In addition, it would be advantageous to provide a tracheostomy tube adapter that properly orients the beveled end 22 of the transtracheal catheter 10 within the tracheostomy tube assembly 34.